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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Linda Kaplan who wrote (6519)	5/10/1999 9:32:00 AM
From: Bob Trocchi	Read Replies (1) \| Respond to of 7041

Linda... >>Headline: NASDAQ HALT - Zonagen Inc. (NASDAQ:ZONA) news pending<< Yes, I just saw this and finally our patience is going to pay off!! Have a GREAT DAY! Bob T.

To: Linda Kaplan who wrote (6519)	5/10/1999 9:54:00 AM
From: Linda Kaplan	Read Replies (1) \| Respond to of 7041

Headline: Zonagen and Schering-Plough Report Status of Vasomax Regulatory Filings ====================================================================== THE WOODLANDS, Texas and MADISON, N.J.--(BW HealthWire)-- May 10, 1999--Zonagen, Inc. (NASDAQ:ZONA) (Pacific:ZNG) and Schering-Plough (NYSE:SGP) today announced that the companies have decided to forego a June FDA Advisory Panel review of the New Drug Application (NDA) for Vasomax(R) until the results of additional clinical studies being conducted by Schering-Plough can be submitted to the FDA. As a result of this decision, Zonagen expects that the FDA will issue a non-approvable letter for the NDA. Vasomax(R) is Zonagen's oral treatment for erectile dysfunction. "Although we are disappointed with this delay, we believe that the additional data from Schering-Plough's studies are important to the long-term success of Vasomax(R)," said Joseph S. Podolski, president and chief executive officer of Zonagen. "Since we began working together in November 1997, we have been impressed by Schering-Plough's ability to further clinical development and plan for the launch of Vasomax(R). Based on this ability, we are confident that this strategy for Vasomax(R) will maximize our product's potential in the marketplace." Zonagen completed two positive pivotal clinical trials that form the basis of the NDA for Vasomax(R). Zonagen and Schering-Plough believe that inclusion of the new data from the ongoing studies should enhance the regulatory filing and the commercial product profile for Vasomax(R). Both companies are committed to obtaining approval of Vasomax with the optimal safety and efficacy product profile. Zonagen expects to submit the data to the FDA as an amendment to the NDA. It was not possible to extend the deadline for completion of the FDA review therefore it was decided to accept a non-approvable letter. Schering-Plough is continuing to seek regulatory approvals for Vasomax(R) in countries outside the United States, having launched the product in Mexico in June 1998 and in Brazil in April 1999. A regulatory application was filed in the United Kingdom in August 1998 as the first step in a mutual recognition procedure for the European Union. Zonagen Inc. is engaged in the development of pharmaceutical products for the reproductive system, including sexual dysfunction, urology, contraception and infertility. Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. A copy of this press release may be obtained via facsimile by dialing 888/329-0920 or via the Internet by accessing www.zonagen.com. ZONAGEN FORWARD-LOOKING STATEMENT: Any statements that are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including but not limited to the Company's early stage of development, clinical trial results and the regulatory process in the U.S. and in other jurisdictions, substantial dependence on one product, history of operating losses, future capital needs and uncertainty of additional funding, litigation, governmental regulation, limited sales and marketing experience and dependence on collaborators, manufacturing uncertainties and reliance on third parties, competition and technological change, and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1998, as filed with the Securities and Exchange Commission. SCHERING-PLOUGH FORWARD-LOOKING STATEMENT: The information in this press release includes certain forward-looking information concerning clinical trials and regulatory approval processes. Due to the nature of the product development and regulatory approval processes, the forward-looking statements contained in this press release are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the forward-looking statements. For further details and a discussion of these risks and uncertainties, see the company's Securities and Exchange Commission filings, including Exhibit 99 of the company's 1998 annual report on Form 10-K. CONTACT: Zonagen Jean Anne Mire, 281/719-3491 or Schering-Plough William O'Donnell, 973/822-7476 KEYWORD: INTERNATIONAL LATIN AMERICA EUROPE TEXAS NEW JERSEY INDUSTRY KEYWORD: MEDICINE Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: businesswire.com Copyright 1999, Business Wire